CTRI Number |
CTRI/2024/01/061925 [Registered on: 29/01/2024] Trial Registered Prospectively |
Last Modified On: |
28/01/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effectiveness of anaesthetic liquid vapour sevoflurane and desflurane from awakening under complete sleep anaesthesia in patients undergoing key hole gall blader operation patients in Regional Institute of Medical Sciences Hospital using randomly selection of patients. |
Scientific Title of Study
|
Comparative study of recovery characteristics between sevoflurane and desflurane in laparoscopic cholecystectomy patients under general anaesthesia in Regional Institute of Medical Sciences Hospital- a randomized clinical trial. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Takhelmayum Hemjit Singh |
Designation |
Assistant Professor |
Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal Lamphelpat, Imphal, Manipur, India. PIN 795004 Imphal West MANIPUR 795004 India |
Phone |
09436021445 |
Fax |
|
Email |
takhelhem@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Takhelmayum Hemjit Singh |
Designation |
Assistant Professor |
Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal Lamphelpat, Imphal, Manipur, India. PIN 795004 Imphal West MANIPUR 795004 India |
Phone |
09436021445 |
Fax |
|
Email |
takhelhem@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Takhelmayum Hemjit Singh |
Designation |
Assistant Professor |
Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal Lamphelpat, Imphal, Manipur, India. PIN 795004 Imphal West MANIPUR 795004 India |
Phone |
09436021445 |
Fax |
|
Email |
takhelhem@yahoo.com |
|
Source of Monetary or Material Support
|
Regional Institute of Medical Sciences, Imphal, Manipur, India |
|
Primary Sponsor
|
Name |
Regional Institute of Medical Sciences |
Address |
Imphal, Manipur, India |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Takhelmayum Hemjit Singh |
Regional Institute of Medical Sciences |
Department of Anaesthesiology, Modular Operation Theatre Complex Imphal West MANIPUR |
09436021445
takhelhem@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Research Ethics Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Use of Desflurane during the maintenace period |
Study participants will be randomized to receive desflurane in concentration decided by haemodynamics and bispectral index scoring for a duration of less than one hour. The study will be conducted for a period of one year. |
Intervention |
Use of sevoflurane during the maintenance period |
Study participants will be randomized to receive sevoflurane in concentration decided by haemodynamics and bispectral index scoring of less than one hour. The study will be conducted for a period of one year. . |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1.Patients of both sex with American Society of Anesthesiologist (ASA) physical grade I or II
2.Patients of age group 18 to 55 years of Manipuri ethnicity undergoing laparoscopic cholecystectomy under general anaesthesia.
|
|
ExclusionCriteria |
Details |
1.History of use of hypnotics or antipsychotics in the last 30 days
2.History of cerebrovascular diseases, chronic kidney diseases, significant cardiovascular diseases, chronic obstructive pulmonary diseases, etc.
3.Pregnant patient, patient refusal and history of allergy to any medication
4.Surgeries lasting more than one hour.
5.Body mass index more than 30 |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The primary outcome of this study will be the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9. |
The assesment will be done from the stoppage of inhalational anaesthetic to spontaneous recovery, i.e at 5 and 10 minutes after the stoppage. |
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary outcomes will includehemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutes, thereafter for every 10 minutes and also at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc |
The recording will be done at 5th, 10th, every 10 minutes intraoperatively and immediate postoperative |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
01/03/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [takhelhem@yahoo.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Sevoflurane and desflurane are the newer inhalational volatile anaesthetics with properties close to ideal and have been an important agent used in the maintenance of anesthesia. Some previous studies have highlighted that desflurane provided rapid and stable emergence than sevoflurane in many surgical day care procedures. Desflurane however has been not used in induction due to its propensity to cause airway irritation, cough, larngospasm and profuse secretion in some studies. Laparoscopic cholecystectomy surgery is usually a minimal invasive one which offers reduced morbidities, lesser operative time and early return to normal activities. The present study will be conducted to compare the recovery characteristics of sevoflurane and desflurane in laparoscopic cholecystectomy under general anaesthesia and will compare the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9. The study has been planned as there is paucity of literatures comparing these two agents on laparoscopic cholecystectomy which is the most common operative procedure in the Institute and it has also not been undertaken in this part of our ethinicity A total of 60 patients, aged 18 to 55 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive Sevoflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters whlie Group B patients will receive Desflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters.The time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9 will be recorded in minutes.The hemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutesthereafter for every 10 minutes and at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc will also be assessed. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference will be drawn. The study will be conducted after getting due approval from the Research Ethics Board of the Institute and after registration with the Clinical Trial Registry of India. |